Publication History

Introduction

Ultrasound Contrast agents (UCA) are considered with a low incidence of side effects (Piscaglia F et al. Ultraschall in Med 2011; 33: 33 – 59). According to the results of clinical trials conducted on SonoVue®, the incidence of adverse events was 10.8 %. The incidence of severe adverse events was very low (0.4 %), with only 3 cases of death (0.06 % of all adverse events) for which it was not possible to exclude an association with SonoVue® (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM252 880.pdf); however, in all these cases, the individuals were already at high risk of severe heart complications which may have been the actual cause of death. SonoVue® is contraindicated in the following individuals: individuals with known hypersensitivity to sulphur hexafluoride or any of its excipients; individuals with recent acute coronary syndrome or unstable cardiac ischemia; individuals with right-left shunt, with severe pulmonary hypertension, uncontrolled hypertension or adult respiratory distress syndrome; pregnant women or women who are breastfeeding. To date, there are no reports of severe adverse events in healthy individuals. We report a case of a severe adverse event in an individual with no clinically significant cardiac or pulmonary pathologies.